MY01 Pressure Monitoring in Adolescent Tibia Fractures

Continuous Compartment Pressure Monitoring in Adolescent Tibia Fractures

The goal of this clinical trial is to learn more about anterior leg compartment pressures in adolescents who have sustained tibia fractures. It will also examine whether measuring anterior compartment pressure helps physicians diagnose acute compartment syndrome (ACS), a rare but dangerous complication that can develop following surgical treatment of a tibia fracture.

The main questions it aims to answer are:

1. Are there differences in anterior compartment pressures between healthy patients and patients who develop ACS?
2. Does compartment pressure monitoring aid physicians in accurately diagnosing ACS?

Participants will have a continuous pressure monitoring sensor placed in their knee anterior knee compartment during their surgery. This sensor will record pressure data following a patient's surgical treatment for 18+ hours.

Study Overview

• Status: Not yet recruiting
• Conditions: Tibial Shaft Fracture; Acute Compartment Syndrome; Proximal Tibia Fracture
• Intervention / Treatment: Device: Continuous Compartmental Pressure Monitor

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristin Livingston, MD; Phone Number: 617-355-6021; Email: kristin.livingston@childrens.harvard.edu
• Study Contact Backup: Name: Sara Olenich, MS; Phone Number: 617-355-6000; Email: sara.olenich@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
      • Contact: Sara Olenich, MS; Phone Number: 617-355-6000; Email: sara.olenich@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Between the ages of 10 to 21 on the day of surgery
• Undergoing operative fixation for a fracture of the proximal tibia or tibial shaft

Exclusion Criteria:

• Preoperative diagnosis of acute compartment syndrome
• Preexisting neuromuscular or vascular condition affecting the injured extremity
• MY01 device malfunction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MY01; All study participants will have an MY01 medical device inserted to record continuous anterior compartment pressure data.	Device: Continuous Compartmental Pressure Monitor; All study participants will have a continuous compartmental pressure monitor placed in the operating room. The pressure sensor will be inserted into the anterior knee compartment, and will remain in place for a minimum of 18 hours postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous anterior compartment pressure	The primary outcome will be continuous anterior compartment pressure measurements, recorded in millimeters of mercury (mmHg) by the MY01 device.	From the placement of the MY01 device sensor to 18 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of acute compartment syndrome	The secondary outcome will be the development of acute compartment syndrome, defined as a clinically diagnosed ACS requiring surgical fasciotomy during index hospitalization. This outcome will be analyzed as a binary variable.	From MY01 device insertion to index hospital discharge, up to 1 week postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurovascular status	The third outcome will be clinical neurovascular status at the initial postop visit. This will be defined as a well-perfused limb with normal distal motor and sensory function as described in the clinical note. This outcome will be analyzed as a binary variable (normal neurovascular status or abnormal neurovascular status). Abnormal neurovascular status will subsequently be defined as the presence of any of the following: abnormal motor function, abnormal sensory function, and/or abnormal vascular status.	First clinic visit following hospital discharge, average of 2-4 weeks postoperatively

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Kristin Livingston, MD, Boston Children's Hospital

Publications and helpful links

Helpful Links

• Continuous Compartment Pressor Sensor Device Manufacturer

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: pediatric; compartment pressure; acute compartment syndrome; Tibia fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: P00054215; 1653422 (Other Grant/Funding Number: Pediatric Orthopaedic Society of North America)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No